Values & services
Vestra Clinics provides added value to sponsors and CROs by being dedicated solely to clinical research.
Vestra Clinics follows the ALOCA-C regulations when creating source documentation.
At Vestra Clinics, all clinical trials are conducted in full compliance with ICH-GCP, US FDA, EMEA, HHS and HIPAA regulations, as well as local regulations. Vestra Clinics has established very stringent internal processes to assure high quality data and financial management. Vestra Clinics has frequently been ranked as the ‘best’ site in multinational trials – highest quality with the highest recruitment rates. We have been ranked first in the world for recruitment in studies sponsored by Axovant, PharmatrophiX, Bial-Portela, GW Research, Bayer, Biomapas, Merz Pharmaceutical, Astellas, Sunovion, AZTherapies, Lundbeck, Teva. Vestra Clinics operations are aligned with the needs of the Sponsor / CRO, as defined in the study protocol and the clinical trial agreement.
Our testimonials show why some of the world’s largest Sponsors and CROs are approaching Vestra Clinics for partnership in clinical trials …
I have been very impressed with the quality of data generated by VestraClinics under the direction of Dr. Pazdera.
The Vestra Clinic was the first active site in our biomarker study in Alzheimer’s patients, and enrolled our first subject into the trial.
The team successfully screened 39 subjects and 26 were randomized. Communications were timely and efficient; timelines were met and audits found no critical or major findings.
Vestra Clinics has the expertise, facilities and vision to conduct your clinical research to the highest standard possible. Our team delivers optimal solutions across the spectrum of services we cover, providing excellent communication, experienced investigators, rigid protocol adherence and streamlined working procedures. Our professional approach also allows us to overcome issues often encountered in clinical trials, such as challenging recruitment.
Vestra Clinics has developed an accurate and efficient system for conducting clinical trials, based around the following key features:
- Highly effective recruitment led by a full-time recruitment experts, with access to a large pool of pre-screened patient population and broad advertisement reach
- Specialized clinical investigators experienced in performing clinical trials
- Stringent internal processes for quality assurance including written study-site standard operating procedures, an induction program for new staff, continued education activities and regular internal compliance reviews.
Vestra Clinics works with a local Ethics Committee (EC) to ensure trial protocols comply with and are performed to local and international regulatory and ethical requirements. The EC complete their review within 1 to 2 weeks (including weekends and holidays), and charge a fixed fee for reviewing industry-sponsored clinical trial protocols.
Vestra Clinics provides timely financial management, with rapid finalization of clinical trial agreements and budget estimates to avoid delays in study initiation. We can complete a trial budget proposal within 7 days of receipt of the final study protocol.